Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

• Status: Completed
• Trial end date: 2020-10-02
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.

Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic.

Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: ATCGen; Complexo Hospitalar do Trabalhador de Curitiba; Complexo Hospitalar Municipal de São Caetano do Sul; Financiadora de Estudos e Projetos; Hospital Central da Aeronáutica, Rio de Janeiro; Hospital da Força Aérea do Galeão; Hospital das Clínicas da Universidade Federal de Pernambuco; Hospital das Clínicas Luzia de Pinho Melo; Hospital das Forças Armadas, Brazil; Hospital de Força Aérea de São Paulo; Hospital Eduardo de Menezes; Hospital Estadual de Doenças Tropicais Dr Anuar Auad; Hospital Geral de Fortaleza; Hospital Geral de São Mateus Dr Manoel Bifulco; Hospital Municipal de Barueri Dr Francisco Moran; Hospital Naval Marcilio Dias; Hospital Regional da Asa Norte, Brazil; Hospital Regional de Sorocaba Dr Adib Domingos Jatene; Hospital Universitario Pedro Ernesto; Mater Dei Hospital, Brazil; Ministry of Science and Technology, Brazil; National Research Council, Brazil; Santa Casa de Misericórdia de Belo Horizonte
• Treatments: Nitazoxanide

Criteria

Inclusion Criteria:

• Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%], admitted to hospital with COVID-19 symptoms associated with chest computed tomography (CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for SARS-CoV2 (RT-PCR)

• Age equal or superior to 18 years

• Non-pregnant women

• Willingness to receive study treatment

• Providing written and informed consent or the same consent signed by a family member

Exclusion Criteria:

• Impossibility to use oral medications

• History of severe liver disease (Child Pugh C class)

• Previous renal failure

• Severe heart failure (NYHA 3 or 4)

• COPD (GOLD 3 and 4)

• Neoplasia in the last 5 years

• Known autoimmune disease

• Individuals with known hypersensitivity to study drug

• Previous treatment with the study medication during the last 30 days

• Clinical suspicion of tuberculosis and bacterial pneumonia